Firms Working to Co-Develop Automated Biotherapeutic Characterization Workflows, Combining Waters LC-MS Instrumentation and Genovis SmartEnzymes

NEWS SUMMARY:

• Collaboration intended to bring speed and simplicity to bio-characterization workflows
• Automated workflows to cut the time and effort required to monitor critical quality attributes of biotherapeutics in regulated laboratories
• Waters and Genovis share goal of advancing the science behind the analysis of glycoproteins and protein therapeutics

Waters Corporation (NYSE: WAT) and Genovis AB (Nasdaq First North Growth Market) are formally collaborating to develop and market complete routine biopharmaceutical characterization workflows based on the Waters™ BioAccord™ LC-MS System, Andrew+ pipetting robot and Genovis SmartEnzymes™. The goal of the collaboration is to develop automated workflows for the rapid and consistent characterization of critical quality attributes (CQAs) of monoclonal antibodies (mAbs) and other protein-based drugs in bioprocess development, formulation, stability testing and quality control (QC).

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“Biologics analysis is an area that is ripe for improvement. What takes analytical scientists several days to do, should take hours or minutes instead,” said Jeff Mazzeo, Vice President, Global Marketing and Scientific Operations, Waters Corporation. “Today, up-front sample preparation is a major bottleneck to productivity, largely due to the number of manual steps involved and the outmoded technology by which samples are readied for analysis. By combining Genovis’ SmartEnzymes with automation, liquid chromatography/time-of-flight mass spectrometry and application-specific software workflows from Waters, we intend to move biotherapeutic analysis forward in ways never thought possible.”

“The BioAccord LC-MS system and the Andrew+ pipetting robot align perfectly with our strategies and vision at Genovis to bring simplified, robust and automated enzyme-driven workflows to the biopharma industry,” said Fredrik Olsson, CEO, Genovis AB. “The enzymatic workflows that we will develop in collaboration with Waters will help our customers in their efforts to bring safe and novel therapeutics to patients, faster.”

The workflows in development are based on the pairing of the Waters BioAccord LC-MS System, Andrew+ pipetting robot and Genovis SmartEnzymes and will focus on addressing the application needs of GxP laboratories in the following areas:

• Product variant analysis [e.g. glycosylation, oxidation]
• Bioprocess stability monitoring
• Biosimilar glycosylation analysis

Additional Resources

• Visit the Waters web site for information on BioAccord LC-MS System for Biopharmaceuticals
• Watch the video Multi-Attribute Method Overview
• Visit the Genovis AB web site for information on Genovis SmartEnzymes
• Read the Genovis blog post Genovis Teams up with Waters to Deliver Enzymatic Workflows for the Biopharma Industry
• Visit the Andrew Alliance website for information on the Andrew+ Pipetting Robot

About Genovis (www.genovis.com)

Genovis’ business concept is to apply its knowledge and customer driven innovation to design and provide tools for the development of the drugs of the future. Today Genovis sells several enzyme products known as SmartEnzymes all over the world in innovative product formats that facilitate development and quality control of biological drugs. The Group consists of Genovis AB and the wholly owned subsidiary Genovis Inc. (US). Genovis shares are listed on Nasdaq First North Growth Market and Erik Penser Bank is the Company’s Certified Adviser, certifiedadviser@penser.se, tel: +46 (0)8-463 83 00.

About Waters Corporation (www.waters.com)

Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, food and environmental sciences for more than 60 years. With more than 7,400 employees worldwide, Waters operates directly in 35 countries, including 14 manufacturing facilities, and with products available in more than 100 countries.

Waters, BioAccord, SmartMS, Andrew Alliance and waters_connect are trademarks of Waters Corporation. SmartEnzymes is a trademark of the Genovis Group.

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We're collaborating with @GENOVIS to combine the BioAccord LC-MS System, Andrew+ pipetting robot and Genovis SmartEnzymes and move biotherapeutic analysis forward in ways never thought possible. #biopharma